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Important Safety Information for Orenitram

Do not take Orenitram if you have severe liver problems.

Before you take Orenitram, tell your healthcare provider if you:

Have liver problems, diverticulosis, or any other medical conditions

Are pregnant, breastfeeding, and/or plan to become pregnant or breastfeed. It is not known if Orenitram will harm your unborn baby or if Orenitram passes into your breast milk. You and your healthcare provider should decide if you will take Orenitram or breastfeed. You should not do both

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Orenitram and other medicines may affect each other causing side effects. Do not start or stop any new medicine until you check with your healthcare provider. Especially tell your healthcare provider if you take another medicine that contains the same ingredient, treprostinil. Know the medicines you take. Keep a list of them and the dose you take to show to your healthcare provider and pharmacist when you get a new medicine.

Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider. Stopping Orenitram suddenly may cause worsening of your PAH symptoms. If you miss two or more doses of Orenitram, call your healthcare provider. If you take too much Orenitram, call your healthcare provider or go to the nearest hospital emergency room right away.

If Orenitram tablets are not taken whole, they may release too much medicine at one time. This can lead to side effects. Do not split, chew, crush, or break your Orenitram tablets. Do not take Orenitram tablets that are damaged or broken. Take Orenitram with food.

Orenitram can cause serious side effects, including an increased risk of bleeding. This risk could be increased if you are taking blood thinners such as warfarin.

The most common side effects of Orenitram include headache, diarrhea, nausea and flushing. These are not all of the possible side effects of Orenitram. Tell your doctor about any side effects that bother you, get worse over time, or do not go away.

Indication

Orenitram is a prescription medicine used to treat pulmonary arterial hypertension (PAH) which is high blood pressure in the arteries of your lungs. Orenitram may improve your ability to exercise. It is not known if Orenitram is safe and effective in children under 18 years of age.

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Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION FOR ORENITRAM

Are pregnant, breastfeeding, and/or plan to become pregnant or breastfeed. It is not known if Orenitram will harm your unborn baby or if Orenitram passes into your breast milk. You and your healthcare provider should decide if you will take Orenitram or breastfeed. You should not do both

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Orenitram and other medicines may affect each other causing side effects. Do not start or stop any new medicine until you check with your healthcare provider. Especially tell your healthcare provider if you take another medicine that contains the same ingredient, treprostinil. Know the medicines you take. Keep a list of them and the dose you take to show to your healthcare provider and pharmacist when you get a new medicine.

Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider. Stopping Orenitram suddenly may cause worsening of your PAH symptoms. If you miss two or more doses of Orenitram, call your healthcare provider. If you take too much Orenitram, call your healthcare provider or go to the nearest hospital emergency room right away.

If Orenitram tablets are not taken whole, they may release too much medicine at one time. This can lead to side effects. Do not split, chew, crush, or break your Orenitram tablets. Do not take Orenitram tablets that are damaged or broken. Take Orenitram with food.

Orenitram can cause serious side effects, including an increased risk of bleeding. This risk could be increased if you are taking blood thinners such as warfarin.

The most common side effects of Orenitram include headache, diarrhea, nausea and flushing. These are not all of the possible side effects of Orenitram. Tell your doctor about any side effects that bother you, get worse over time, or do not go away.

Indication

Orenitram is a prescription medicine used to treat pulmonary arterial hypertension (PAH) which is high blood pressure in the arteries of your lungs. Orenitram may improve your ability to exercise. It is not known if Orenitram is safe and effective in children under 18 years of age.

OREISIdtcJAN16

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.